SOLICITATION NOTICE
R -- Research Study Outreach
- Notice Date
- 8/16/2017
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-17-651
- Archive Date
- 9/15/2017
- Point of Contact
- Sneha V Singh, Phone: 3014802443
- E-Mail Address
-
sneha.singh@nih.gov
(sneha.singh@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NOTICE OF INTENT INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute of Mental Health intends to negotiate and award a contract for research study outreach support. EXTENT OF COMPETITION This acquisition is full and open with no set-aside restrictions. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 - All Other Professional, Scientific, and Technical Services with a Size Standard of $15M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-95, 19 Jan, 2017. This acquisition is conducted under the procedures as prescribed in the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures at an amount not expected to exceed the Simplified Acquisition Threshold inclusive of options. DESCRIPTION OF REQUIREMENT Project Description The Mood, Brain & Development Unit (MBDU) and the Section on Mood Dysregulation and Neuroscience in the National Institute of Mental Health Intramural Research Program are studying the brain mechanisms underlying depression, irritability, and other mood disorders. The research studies include inpatient and outpatient protocols including evaluation and treatment studies. A crucial part of the work done at MBDU is the recruitment of sufficient numbers of appropriate participants for our studies. Purpose and Objectives A key aspect of clinical research is patient sampling, that is, the recruitment of appropriate numbers of appropriate patients into research studies. Our Branch has a track record of such recruitment but as our work is expanding, we want to increase number of people recruited and refine the criteria for recruitment, for example through recruiting people who are not on medication. The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The contractor shall provide a detailed strategic plan for recruitment, detailing processes for each objective. The contractor shall provide monthly updates on referrals, source of referrals, and adjusted recruitment plan based on referral sources and efforts. The contractor shall recruit patients for our research purposes as specified below. Project Requirements The contractor shall have a substantial track record of successfully recruiting participants into research. The contractor shall conduct an evaluation scan and analysis to determine the most effective outreach strategies for patients of this population, 7-17 years old with major depressive disorder or irritability or ADHD, and not currently taking medications. In particular, the contractor shall conduct recruitment of patients to obtain the following samples: 1. Depression: The contractor shall recruit patients at least n=100 subjects, aged 12-17 years old who also meet the following criteria: a) Score 25 or above on the self-reported Mood and Feelings Questionnaire (MFQ) and 25 or above on the parent-reported Mood MFQ. b) Are not on any psychotropic medication and have not been on any psychotropic medication for at least three months. c) Scores below 8 on the social communication questionnaire (SCQ) d) Have no existing diagnosis of schizophrenia or other psychotic or substance abuse disorder. e) Reside with their families within a radius of 75 miles from the National Institute of Mental Health in Bethesda, MD. f) Be willing in principle to participate in research, including fMRI scanning, at the National Institute of Mental Health in Bethesda, MD. g) Not have contraindications for MRI scanning (e.g., braces or other metal in body, claustrophobia, etc.). 2. Irritability: The contractor shall recruit into our study at least n=100 subjects, aged 7-17 years old who also meet the following criteria: a) Score 4 or above on the parent-rated Affective Reactivity Index (ARI), and endorse the "somewhat" or "certainly true" levels on the last (seventh) item of the ARI. b) Scores below 8 on the social communication questionnaire (SCQ) c) Have no existing diagnosis schizophrenia or other psychotic or substance abuse disorder. d) Are not on any psychotropic medication and have not been on any psychotropic medication for at least three months e) Reside with their families within a radius of 75 miles from the National Institute of Mental Health in Bethesda, MD. f) Be willing in principle to participate in research, including fMRI scanning, at the National Institute of Mental Health in Bethesda, MD. g) Not have contraindications for MRI scanning (e.g., braces or other metal in body, claustrophobia, etc.). 3. ADHD: The contractor shall recruit at least n=100 subjects, aged 7-17 years old who also meet the following criteria: a) By parent report, on the 1-item Swanson, Nolan and Pelham (SNAP) Questionnaire, if a child has a mean score of 1 on any of the 3 index [ADHD inattention (mean of items 1-9), ADHD hyperactivity-impulsivity (mean of items 10-18), or ADHD-combined (all items)], they should screen positive for us to pursue as an ADHD. Note, the 4-point response is scored 0-3 (Not at All=0, Just A Little=1, Quite a Bit=2, and Very Much=3). Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the specific subset (e.g., Inattention) and dividing by the number of items in the subset (e.g., 9). The score for any subset is expressed as the Average Rating Per Item. b) Have a score lower than 3 and endorse "not true" on the last (seventh) item on the ARI. c) Scores below 8 on the social communication questionnaire (SCQ). d) Be on no psychotropic medication, with the exception of short-acting stimulants that can be withheld for 48 hours for the purpose of fMRI scanning. e) Has no existing diagnosis of schizophrenia or other psychotic or substance abuse disorder. f) Reside with their families within a radius of 75 miles from the National Institute of Mental Health in Bethesda, MD. g) Be willing in principle to participate in research, including fMRI scanning, at the National Institute of Mental Health in Bethesda, MD. h) Not have contraindications for MRI scanning (e.g., braces or other metal in body, claustrophobia, etc.). i) The contractor shall identify these individuals through their preferred route of recruitment, but must comply with general good practices and ethical conduct in recruiting subjects for medical research. All strategies must be approved by the NIMH IRB. These include, but are not restricted to the following: • Document consent of participants to have data shared with researchers; • Any online activity or ad should have a clear privacy statement and there should be a policy in place that assures privacy and confidentiality are protected, as well as be clear on the individuals' right to withdraw from a study; • Recruitment shall not be done on the basis of individuals' internet search histories for mental health conditions, unless it is clear that such individuals were interested in research participation; The recruitment rate (n=100) for each depression, irritability, and ADHD is defined as number of people with the characteristics specified above who have contacted MBDU via email or phone within one year. Those that do not, will still be reflected in the study. The contractor shall provide a plan to be utilized to meet the requirements outlined above. The contractor shall be responsible for all recruitment costs, including but not restricted to, strategies about how to recruit, the cost of advertisement and outreach. The contractor shall execute the plan, and is responsible for the successful completion of any outreach activities to secure research participation. Such activities may include, but not be limited to, community engagement, and other activities. Period of Performance One year from date of award. The Government contemplates a Firm-Fixed-Price Purchase Order for non-commercial items. CLOSING STATEMENT The solicitation will be issued on or about September 1, 2017, and bids or proposals will be tentatively due about 10 days after the solicitation release date. Potential offerors may request a copy of the solicitation from the Sneha Singh electronically at sneha.singh@nih.gov and must reference the solicitation number HHS-NIH-NIDA-SSSA-NOI-17-651, on your electronic request. FAX requests are not accepted.
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